Otc - Active Ingredient
Eucalyptol 0.092%
Menthol 0.042%
Methyl sailcylate 0.060%
THYMOL 0.064%
Antiseptic Mouth Rinse
FDA Label NDC 42507-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hy-vee, Inc for the product Antiseptic Mouth Rinse (NDC 42507-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAntigingivitis
Indications & Usage
Use helps control plaque that leads to gingivitis
Warnings
Warnings
Otc - Do Not Use
Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease
Otc - Stop Use
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
adults and children 12 years
of age and older - vigorously swish20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age - consult a dentist or doctor
of age and older - vigorously swish20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age - consult a dentist or doctor
• this rinse is not intended to replace brushing or flossing
Storage And Handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰- 77⁰F)
Inactive Ingredient
Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40
Other
This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
Adverse Reactions
DISTRIBUTED BY HY-VEE, INC
5820 WESTOWN PARKWAY
WEST DES MOINES, IA 50266
SATISFACTION GUARANTEED
OR PURCHASE PRICE REFUNDED
FOR INFORMATON CALL
1-800-289-8343
www.hy-vee.com
Package Label.Principal Display Panel
Compare to active ingredientsin Citrus Advanced Listerinewith Tartar ProtectionTartar ControlAntisepticMouth RinseCitrus•Helps fight tartar buildup•Fights plaque + gingivitis•Kills germs for extended plaque protection•Enhanced breath protection1.5 LITERS (50.7 FL OZ)
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